The investigators would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Enrollment:

88

Study Start Date:

January 2006

Study Completion Date:

January 2009

Primary Completion Date:

January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

There have been tremendous advances in the treatment of HIV by combining 3 to 4 of the 20 anti-HIV medications available. Despite these advances, there remain several important complications related to the treatment, most importantly adverse events like nausea, diarrhea, liver toxicity and lipodystrophy (fat wasting or accumulation). Some studies have found that drug levels are higher in women and that these higher drug levels are associated with the increased toxicity in women. The reasons for the higher drug levels remain unclear. It is unknown whether these relate to hormonal influences, drug metabolism, adherence, fat distribution, body size or other factors. For this reason, we would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

HIV positive patients

Criteria

Inclusion Criteria:

Are HIV infected

Are 18 years old or older

A biologic woman

Are taking their first combination Anti-retroviral regimen that includes a Protease Inhibitor or a Non-Nucleoside Reverse Transcriptase Inhibitor for the past three months with no changes in any part of the combination in that period

Are taking either a Protease Inhibitor or an Non-Nucleoside Reverse Transcriptase Inhibitor but not both

If taking a Protease Inhibitor, must be taking only one Protease Inhibitor excluding low dose ritonavir used as boosting

Have a viral load < 50 copies/mL on two occasions at least 1 month apart including a value at least three months before the baseline visit

Have signed and dated a full informed consent

Exclusion Criteria:

Have difficulty participating in a trial due to non-adherence or substance abuse

Pregnant or breast-feeding

Have malignancy receiving systemic chemotherapy

Have end-stage organ disease

Have another significant non-HIV underlying disease that might impinge upon disease progression or death

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613157